Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (January 2021)
71 slides from Soligenix's investor presentation, Jan 26, 2021
Slide 1: Investor Update: U.S. Commercialization of SGX301 in CTCL
(GSOLIGENIX a Investor Update U.S. Commercialization of SGX301 in the Treatment of Cutaneous T-Cell Lymphoma January 26, 2021
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements. All statements other than statements of historical acts contained in this presentation, including statements regarding our future results of operations and inancial position, business strategy, prospective products and
Slide 3: Welcome & Agenda
Welcome & Agenda Today’s Objectives Provide an overview of the CTCL treatment landscape Provide an overview of the SGX301 U.S. commercialization plan Discuss the value proposition for SGX301 Today's Agenda CEO's Introduction (C. Schaber) CTCL Overview & Current Treatment of Early-Stage Disease (Dr.
Slide 4: U.S. commercialization of SGX301
U.S. commercialization of SGX301 a First-in-Class Therapy Framework for commercialization success in the U.S. We have compelling Phase 3 data where there is no FDA approved first-line therapy and where a clear unmet medical need exists We have established strong relationships with many KOLs during t
Slide 5: SGX301 Treatment Regimen
SGX301 Treatment Regimen 'SGx301 = ‘7 > Patient applies topical synthetic > Visible non-UV light therapy hypericin ointment at home 18- administered for about 4-7 24 hours prior to visiting office minutes 2x week by physician or for - ~~ nurse technician in office
Slide 6: SGX301 a Significant Near Term Commercial Opportunity Addressing a Clear Unmet Need
SGX301 a Significant Near Term Commercial Opportunity Addressing a Clear Unmet Need Unmet Need Positive Feedback Source: Soligenix primary market research > Clinicians see need for additional treatment options with fewer side effects Most patients cycle through several treatments over course of thei
Slide 7: Agenda
Agenda > CEO's Introduction > CTCL Overview & Current Treatment of Early-Stage Disease > SGX301 Phase 3 Data > A Practitioner’s View of the Phase 3 Data
Slide 8: Ellen Kim, M.D.
Ellen Kim, M.D. > Professor of Dermatology, > Medical Director, Perelman Center for Advanced Medicine Dermatology Clinic, Hospital of the University of Pennsylvania, Philadelphia, PA. » Lead Principal Investigator in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial
Slide 9: Cutaneous T-Cell Lymphoma - Disease Overview
Cutaneous T-Cell Lymphoma - Disease Overview Cutaneous T-cell lymphoma (CTCL) Rare class of Non-Hodgkin's Lymphoma (NHL) Malignant T-cells migrate to the skin Cancer forms patches, lesions or tumors CTCL affects over 40,000 NHL patients worldwide; currently no cure Two main subtypes of CTCL Mycosis
Slide 10: Mycosis Fungoides
Mycosis Fungoides Rare primary cutaneous T-cell lymphoma Derived from skin homing T-cells Sporadic Scaly patches, plaques in a “bathing trunk distribution” Chronic, recurrent Mimics benign conditions Can progress: tumors, erythroderma De novo erythroderma, LAD, keratoderma: Sezary Syndrome
Slide 11: Disease Staging
Disease Staging EARLY STAGE IA (T1a, T1b -limited patches or plaques) IB (12a, T2b - generalized patches or plaques) IIA (patch/plaque & reactive N1 nodes) ADVANCED STAGE IIB (T3, tumor) Ill (T4, erythroderma >= 80% BSA) IVA (B2 blood and/or N3 nodal disease)
Slide 12: Stage IA MF/CTCL: Overall survival
Stage IA MF/CTCL: Overall survival Same as age matched controls A 100-5, iA IB ve A 1B 80- —=IlA < WB — (VAI os = =IVA2 Zz f z 604 we 5 wn Ss => z = 40-4 [s-J 2 [=) a 20- \ L 1 oO 5 10 20 30 Time Since Diagnosis (years) SOLIGENIX, Agar et al. JCO. 2010
Slide 13: Mycosis Fungoides/Sezary Syndrome Prognosis
Mycosis Fungoides/Sezary Syndrome Prognosis Overall 5-year survival: 74.5% Stage IA 94% Stage IVA1 37% Median survival of Sezary Syndrome pts = 3.1 yrs Disease progression in 34% of pts T1a (limited patch) = 9% T4 (erythrodermic) = 66%
Slide 14: Early-Stage disease (IA-IIA)
Early-Stage disease (IA-I|A) 70% of all MF/SS patients have early-stage disease Patients with limited patch disease T1a do not need extensive staging work up (flow cytometry blood, scans), and can pursue active surveillance. 85% will need only skin directed therapy Active surveillance for T1a asympt
Slide 15: Treatment goals
Treatment goals Improve skin appearance & symptoms >= 50% baseline Can take 4-24 months for full response May need maintenance therapy Can repeat prior prescriptions Cost considerations are important Cure: not possible in most patients Minimize long term toxicity of skin treatment Key concerns: NMSC
Slide 16: Current CTCL Treatment Map
Current CTCL Treatment Map Low 4 Topical Corticosteroids Mechlorethamine gel TOPICAL TX Photopheresis PUVA+IFN/Other Disease Severity Oral Bexarotene Electron Beam ’ emotherapy/Allo High | chemotnerny/Alscr Therapy Armnementarium Diagram adapted from: M. Duvic, Hematology , Dec2015 SOLIGENIX,
Slide 17: Principles of Skin Directed Therapies
Principles of Skin Directed Therapies 70% of MF/CTCL at diagnosis have early-stage disease (Stage IA-IIA) MF/CTCL is an incurable chronic, indolent disorder in most patients Symptoms of early MF/CTCL include itch, burning, scaling, cosmetic disfigurement Skin directed therapies (SDTs) are the primar
Slide 18: Current Treatment Guidelines
Current Treatment Guidelines National Comprehensive NCCN Guidelines Version 1.2021 Mycosis Fungoides/Sezary Syndrome Cancer Network® SUGGESTED TREATMENT REGIMENS?® SKIN-DIRECTED THERAPIES Skin-Limited/Local (For limited/localized skin involvement) (in alphabetical order) Skin-Generalized (For genera
Slide 19: Benefits and Risks of Skin Directed Therapies
Benefits and Risks of Skin Directed Therapies Topical steroids Inexpensive, available, work quickly CONS: Not approved for CTCL, long term use - atrophy, striae, easy bruising, systemic absorption (secondary adrenal insufficiency), compatible with many other SDTs Topical retinoids (bexarotene, tazar
Slide 20: Benefits and Risks of Skin Directed Therapies
Benefits and Risks of Skin Directed Therapies Topical imiquimod* - topical immunotherapy (TLR agonist) Can use in genital area safely, can see responses relatively soon (6-12 weeks) CONS: cost, high incidence of inflammation at application site, only available in small quantities so can only do loca
Slide 21: Benefits and Risks of Skin Directed Therapies
Benefits and Risks of Skin Directed Therapies > Radiation therapy Localized - readily available Generalized - Total skin electron beam - only available at specialized centers Highly effective, more effective than topicals or phototherapy for plaque/tumor disease, relatively quick time to response. C
Slide 22: Use of Skin Directed Therapies in MF/CTCL
Use of Skin Directed Therapies in MF/CTCL No one “best” therapy - few large randomized controlled trials comparing agents Initial choice will depend on many factors - type of skin lesions, location, co-morbidities, patient's insurance plan, physician preference. Most patients will end up utilizing m
Slide 23: Agenda
Agenda > CEO's Introduction > CTCL Overview & Current Treatment of Early Stage Disease > SGX301 Phase 3 Data > A Practitioners’ View of the Phase 3 Data
Slide 24: Ellen Kim, M.D.
Ellen Kim, M.D. > Professor of Dermatology, > Medical Director, Perelman Center for Advanced Medicine Dermatology Clinic, Hospital of the University of Pennsylvania, Philadelphia, PA. » Lead Principal Investigator in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial
Slide 25: SGX301 Phase 3 FLASH Trial
SGX031 Phase 3 FLASH (Fluorescent Light Activated Synthetic yi” Trial yay —_— x 4 Ye
Slide 26: SGX301 Treatment Regimen
SGX301 Treatment Regimen 'SGX301 era sree te > Patient applies topical synthetic > Visible non-UV light therapy hypericin ointment at home 18- administered for about 4-7 24 hours prior to visiting office minutes 2x week by physician or for - _— - _ in ~
Slide 27: Mechanism of Action of Hypericin
Mechanism of Action of Hypericin Hypericin Supercharged by Visible Light Hypericin X oxygen Visible Light Hypericin Free Localized, 500-650 nm (ground state) radicals, directed, (Yellow) singlet cellular oxygen toxicity
Slide 28: Pivotal Phase 3 FLASH Trial Design Challenges
Pivotal Phase 3 FLASH Trial Design Challenges >» CTCL is an indolent disease but is cancer o Prolonged use of placebo problematic o 2months of placebo considered longest period acceptable > CTCL prevalence is low o Study needed to be appealing for both recruiting and retention
Slide 29: Pivotal Phase 3 FLASH Trial Design
Pivotal Phase 3 FLASH Trial Design Phase 3, placebo-controlled, double-blind, multi-center pilot study 169 patients with Stage IA, IB or IIA CTCL Randomized 2:1 0.25% SGX301 ointment to placebo Opaque covering 18-24 hours after application, fluorescent bulb, cool-white, light therapy Three cycles of
Slide 30: Pivotal Phase 3 FLASH Trial Design
Pivotal Phase 3 FLASH Trial Design Cycle 1 Double-blind 3 index lesions treated Primary efficacy (biologic activity) endpoint for trial Cycle 2 Open-label 3 index lesions treated Extended clinical efficacy endpoint for trial Cycle 3 Optional, compassionate-use
Slide 31: Pivotal Phase 3 FLASH Trial Endpoint
Pivotal Phase 3 FLASH Trial Endpoint Primary Endpoint- Cycle 1 Percent of patients achieving a treatment success (250% improvement) Assessed with the standard Composite Assessment of Index Lesion Severity (CAILS) scoring system Cumulative score of the 3 index lesions at the Cycle 1 evaluation visit
Slide 32: Efficacy of SGX301
Efficacy of SGX301 Cycle 1: Primary Endpoint statistically significant (p=0.04) Cycle 2: Statistically significant improvement in treatment response to 40% (p<0.0001) after additional 6 weeks of therapy Optional (safety) Cycle 3: Statistically significant improvement in treatment response to 5, ine
Slide 33: Skin Penetration of Light Wavelengths
Skin Penetration of Light Wavelengths SGX301 + Sebaceous gland— Visible Light Mel te ie] 2 a a jelanocyte o = S, 5 $s = gz - S&S & S & & = =) | 5 5 EPIDERMIS s&s 2 y if DERMA L 7 FAT
Slide 34: Efficacy of SGX301 In Patch and Plaque Lesions
Efficacy of SGX301 In Patch and Plaque Lesions Efficacy seen in patch (no lesion elevation), plaque (lesion elevation) and even thick (>1 mm raised) plaque lesions a o —® Patch “® Plaque Thick Plaque nv o s ° o o Percent Responders S 0 5 10 15 20 Week UV treatments known to be useful — i but _ in
Slide 35: Expected Safety of SGX301
Expected Safety of SGX301 >» Non-mutagenic > Minimized exposure of healthy skin to drug o Applied only on cancerous lesions > Minimizes healthy cell damage o Selective uptake by malignant cells o Selective uptake in malignant T-cells compared to healthy T-cells of 10- to
Slide 36: Safety of SGX301
Safety of SGX301 > SGX301 treatments well tolerated o Severe acute adverse events reported in <2% of patients requiring discontinuation of treatment (burning sensation with light therapy) o Other therapies with up 25% acute discontinuation due to severe allergic reactions, blistering and skin infect
Slide 37: Agenda
Agenda > CEO's Introduction > CTCL Overview & Current Treatment of Early Stage Disease > SGX301 Phase 3 Data > A Practitioner’s View of the Phase 3 Data
Slide 38: Brian Poligone, M.D., Ph.D.
Brian Poligone, M.D., Ph.D. Expertise in Clinical Trials for Mycosis Fungoides and as a Basic Lab Scientist studying mouse models Director of Cancer Biology Research Rochester Skin Lymphoma Medical Group, PLLC Dermatology and Post-doc Fellowship in Immunology-Yale Internship-Stanford Medical School
Slide 39: My Experience With SGX301
My Experience With SGX301 Lead Enroller in the FLASH Study In my opinion, there is a need NOW for this therapy No cure exists for early-stage disease My preference in early-stage disease is to treat patients: Through skin directed therapies whenever possible Have my patients on a therapy that is eff
Slide 40: What I Have Seen With My Patients
What | Have Seen With My Patients All of my patients showed benefit of treatment with SGX301 The application of the drug was: Simple and intuitive for my patients Accomplished without issue and delivered precisely to active disease The administration of the light therapy: Standard and quick Provided
Slide 41: How SGX301 Compares to Current Therapies
How SGX301 Compares to Current Therapies > Available therapies are either not indicated for CTCL or indicated as 2" line o No currently available treatments for my patients are approved as 1% line > SGX301 would not have these limitations > Ability to prescribe it 1$t line to ALL of my earl patients
Slide 42: How SGX301 Compares to Available Topical Therapies
How SGX301 Compares to Available Topical Therapies > Most topical therapies currently available are: o Notas effective as desired o Are not as well tolerated due to side effects > SGX301 was very well tolerated > We saw effect in reduction of disease and symptoms quickly > Many of the patients showe
Slide 43: How SGX301 Compares to Available Phototherapy
How SGX301 Compares to Available Phototherapy Ultraviolet Therapy carries inherent risks and limitations Patients have a risk of developing skin cancers We are generally “capped” at the total number of light treatments due to this increased risk from cumulative exposure Phototherapy treats the entir
Slide 44: SGX301 is Effective Across All Early-Stage Disease Types
SGX301 is Effective Across All Early-Stage Disease Types SGX301 efficacy on patch and plaque type disease is very compelling and unique Other skin directed therapies are less effective in thicker plaque type disease, limiting my treatment choices SGX301 is not limited by disease type | can and have
Slide 45: SGX301 Has Shown Efficacy In Rare, Hard To Treat CTCL Subsets
SGX301 Has Shown Efficacy In Rare, Hard To Treat CTCL Subsets SGX301 + Visible Light Certain subtypes of disease with deeper tissue level of involvement such as folliculotropic vsonsoe mycosis fungoides are more difficult to treat vounn Sebaceous gland mm nid 14617 uee15 14617 Mojja, 61] pay SGX301
Slide 46: Takeaways of SGX301 Data From My Clinical Perspective
Takeaways of SGX301 Data From My Clinical Perspective Effective in treating early stage CTCL Effect is noted early in treatment and continues to increase over time Well Tolerated Compared to other therapies, the side effect profile is very low Patients were able to continue on therapy The combined s
Slide 47: My Clinical Perspective On SGX301
My Clinical Perspective On SGX301 SGX301 could be an option considered for all early-stage patients Fills a current need in the treatment landscape Continue to treat to maximal effect Maintenance therapy The avail
Slide 48: Agenda
Agenda > CEO's Introduction > CTCL Overview & Current Treatment of Early Stage Disease > SGX301 Phase 3 Data > A Practitioner's View of the Phase 3 Data
Slide 49: Michael W. Young
Michael W. Young Chief Marketing Officer (Acting) / Strategic Consultant Oncology/Hematology Commercial Leader Head of Marketing - Ligand Pharmaceuticals VP, Strategy - Klick Health (Digital Health) VP, Business Dev - PAREXEL, PPD (CROs) 20+ global product launches including Targretin, Targretin gel
Slide 50: Early stage CTCL is a chronic disease with a high unmet medical need
Early stage CTCL is a chronic disease with a high unmet medical need Cutaneous T-cell lymphoma (CTCL), is a rare, indolent form of Non-Hodgkin's CTCL Patient Stratification by Stage* Lymphoma (NHL), ~4% of all NHL 1% 2% Typical time to first diagnosis = 5 years (trained dermatologist, skin biopsy) A
Slide 51: Early stage CTCL is typically diagnosed and treated by Dermatologist KOLs at CTCL Centers of Excellence
Early stage CTCL is typically diagnosed and treated by Dermatologist KOLs at CTCL Centers of Excellence Initial }H—_ Diagnosis presentation 8 Primary Care Community Physician Dermatologist Patient with Ifa Derm is not comfortable undiagnosed MF managing ME, they will refer to a CTCL center Community
Slide 52: The Dermatologist KOLs play a pivotal role in the treatment of early stage CTCL
The Dermatologist KOLs play a pivotal role in the treatment of early stage CTCL O Most patients who go to a KOL for diagnosis will stay with the KOLs for or their care and treatment reasons or travel distances) the KOL stays involved and directs the care through the local dermatologist There is a su
Slide 53: Significant Opportunity for Improvement to Current Treatment Paradigm for Early Stage CTCL
Significant Opportunity for Improvement to Current Treatment Paradigm for Early Stage CTCL Early Stage CTCL Treatment Paradigm Current Treatment Landscape 7 Because of chronic nature of early stage CTCL and long-term treatment cycles, clinicians choose therapies . . with better safety profiles first
Slide 54: Lack of satisfaction with current therapies provides an opportunity for SGX301
The incurable nature of early stage CTCL, lack of Satisfaction with current therapies and long duration of treatment, provides an opportunity for SGX301 Early stage CTCL is a chronic condition and Lines of Therapy he market is unsatisfied with current reatments @ Dermatologist Oncologist Therapies a
Slide 55: The profile of SGX301 is seen as superior to existing therapies
The profile of SGX301 is seen as superior to existing therapies for early stage CTCL Derms like that SGX301 is equally effective on both patches and plaques (response rate of 37%, p=0.0009 and 42%, p<0.0001, respectively) after 12 weeks of treatment; hey feel that nbUVB has reasonable efficacy on pa
Slide 56: SGX301 will be rapidly integrated into most physicians' clinical practices
SGX301 will be rapidly integrated into most physicians’ clinical practices Projected Usage of SGX301 Vast majority of prescribers will immediately switch some patients to SGX301 upon FDA approval so | 47% While topical steroids remain a common 1** line Tx, SGX301 expected to be used in 20%-30% of 1%
Slide 57: Physician perceptions of SGX301 are positive
Physician perceptions of SGX301 are positive & 5 “.. You get 40% reduction, 50% reduction in a “I'd be very likely to prescribe it... because plaque in the first 12 weeks. That's comparable there are not a lot of options that are or probably even better than what UVB could available for patients wit
Slide 58: SGX301 will be adopted rapidly and used ahead of currently available therapies
SGX301 will be adopted rapidly and used ahead of currently available therapies Very Few Patients IA IB/IIA IIB tl IV (limited patch, plaque) (generalized (tumors) (erythroderma) (nodal/visceral patch, plaque) involvement) TOPICALTX Mechlorethamine gel NB UVB" * Subject to FDA approval. Source: Solig
Slide 59: Phototherapy is a mainstay treatment of early stage CTCL
Phototherapy is a mainstay treatment of early stage CTCL SGX301 Treatment Regimen poxa0) Patient applies topical Visible non-UV light synthetic hypericin therapy administered ointment at home for about 4-7 minutes 18-24 hours prior to 2x week by physician visiting office for light or nurse technicia
Slide 60: We have forged a partnership with Daavlin
We have forged a partnership with Daavilin, a global leader in phototherapy products We have an exclusive Manufacturing, Distribution and Services Agreement with Daavlin Daavlin is a leading manufacturer of phototherapy products used world-wide by dermatologists and patients to treat skin disorders
Slide 61: The Soligenix-Daavlin partnership provides a complete end-to-end business solution
The Soligenix-Daavlin partnership provides a complete end-to-end business solution for our physician customers Reimbursement Support SOLIGENIXg Daaviin Customer Call Center Daa slin Goin Ordering & Delivery to clinic and home Daavlin Clinical Support SOLIGENIX, Co-Pay Support SOLIGENIX, Maintenance
Slide 62: The companion light device is ready for commercialization
The companion light device was developed to be used specifically with SGX301 and is ready for commercialization Leveraged an existing light platform that Daavlin has produced and sold for more than 10 years 5) Developed to be used specifically with SGX301 Equipped with Daavlin’s latest touch screen
Slide 63: A concentrated prescriber base allows for an efficient commercial footprint
A concentrated prescriber base allows for an efficient commercial footprint Planned launch focused on high volume specialists and their referral base in the community Likely sales force deployment of ~20 reps; reaching >80% of high volume prescribers Ww Cutaneous Lymphoma ° = Treatment Center @ | L
Slide 64: Payers are likely to cover the drug and light treatment
Payers are likely to cover the drug and light treatment if it is shown to be safe and efficacious SGX301 drug product will be covered under Medicare Prescription Drug Part D As a rare disease, CTCL treatment does not have a large financial impact on payers Payers expect to require only a simple prio
Slide 65: Total U.S. revenues during the forecast period > $700M
Total U.S. revenues during the forecast period > $700M Pre-launch costs of ~$7M, annual marketing and sales costs of <$10M $100.0 $92.5 $88.1 $80.0 $83.8 $79.8 $75.9 72.3 $68.8 : $60.0 $65.5 $40.0 $46.8 Launch $20.0 4Q22 $25.2 $7.1 $- 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 - * Orphan
Slide 66: Competing products have achieved a level of commercial success
Competing products have achieved a level of commercial success despite having inferior profiles compared to SGX301 Product Price Sales (est.) | Indication VALCHOR® ~ $4,000 $40 M 24 line (mechlorethamine) per60gmtube | : TARGRETIN® gel ~$32,000 $30 M 2" line (bexarotene) per 60 gm tube i $20 - $200
Slide 67: Brand name and logo for SGX301 submitted to FDA
The proprietary brand name and logo for SGX301 have been developed and the brand name has been Submitted to FDA for approval _> ‘A | ™ ) |p} a 7 , ee , aA | a ! : 17 A i £. _w @ 7 eae OT © ££» “ Y | ) Vv , , | Yi ! = - | wWaeté = La \ aw . 4 Zs Ff -_ > _. | | » | ff (hypericin) ointment 0.25% ~~
Slide 68: Regulatory Status of SGX301
Regulatory Status of SGX301 FDA Orphan Drug and Fast Track designations granted UK MHRA Promising Innovative Medicine designation granted Anticipated submission timeline All patient visits completed Final database lock and completion of Clinical Study Report Q2 2021 Initial submission of the rolling
Slide 69: Life cycle management planning includes potential for home use and expanded uses
Life cycle management planning includes potential for home use and expanded uses Commercial Launch 12-18 months
Slide 70: SGX301 a Significant Near Term Commercial Opportunity Addressing a Clear Unmet Need
SGX301 a Significant Near Term Commercial Opportunity Addressing a Clear Unmet Need Unmet Need Positive Feedback Source: Soligenix primary market research > Clinicians see need for additional treatment options with fewer side effects Most patients cycle through several treatments over course of thei
Slide 71: Questions?
Questions? | (SOLIGENIX